MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-14 for EVOLUTION? DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED EVO-22-27-9-D manufactured by Cook Ireland Ltd.
[189071769]
Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions. Pma/510(k) #: k163468.
Patient Sequence No: 1, Text Type: N, H10
[189071770]
According to the user, the reported stent separation has not occurred actually. Overgrowth and ingrowth of tumor occurred and the center of the stent was covered by the tumor. Therefore, the user mistook the growth of tumor for stent separation competitor's stent was placed on (b)(6) 2019. There have been no adverse effects to the patient reported. According to the sales rep, it is difficult to get further information for this complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001845648-2020-00027 |
| MDR Report Key | 9586065 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-14 |
| Date Mfgr Received | 2019-12-18 |
| Date Added to Maude | 2020-01-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. HEATHER RYAN |
| Manufacturer Street | O HALLORAN ROAD NATIONAL TECHNOLOGY PARK |
| Manufacturer City | LIMERICK |
| Manufacturer G1 | COOK IRELAND LTD |
| Manufacturer Street | O HALLORAN ROAD NATIONAL TECHNOLOGY PARK |
| Manufacturer City | LIMERICK |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVOLUTION? DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED |
| Generic Name | MUM STENT, METALIC EXPANDABLE, DUODENAL |
| Product Code | MUM |
| Date Received | 2020-01-14 |
| Catalog Number | EVO-22-27-9-D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK IRELAND LTD |
| Manufacturer Address | O HALLORAN ROAD LIMERICK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-01-14 |